Sterrad Cyclesure Biological Indicator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K103222 FDA 510(k)
- FDA Product Code
- FRC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2800 FDA 510(k)
- Regulation Number
- 880.2800 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sterrad Cyclesure Biological Indicator is a Biological Sterilization Process Indicator designed to validate the effectiveness of sterilization cycles in hydrogen peroxide-based systems. It employs a self-contained biological monitor containing Bacillus stearothermophilus spores to detect residual microbial contamination after sterilization, ensuring process integrity and compliance with sterilization protocols.
This indicator is supplied as a single-use, non-sterile device consisting of a plastic vial with a glass fiber disc impregnated with spores. It is intended for use exclusively with Sterrad sterilization systems and requires no additional preparation beyond placement within the sterilizer chamber. The device is regulated under FDA 510(k) clearance (K103222) and classified as a Class II medical device, adhering to sterilization validation standards for general hospital use.
Frequently asked questions
What is the Sterrad Cyclesure Biological Indicator used for in a hospital setting?
The Sterrad Cyclesure Biological Indicator is designed to validate the effectiveness of hydrogen peroxide-based sterilization cycles in Sterrad systems. It contains *Bacillus stearothermophilus* spores on a glass fiber disc to detect residual microbial contamination after sterilization, ensuring the process meets sterilization validation standards for general hospital use.
How is the Sterrad Cyclesure Biological Indicator supplied and prepared for use?
It is supplied as a single-use, non-sterile device in a plastic vial containing a pre-impregnated glass fiber disc with spores. No additional preparation is required beyond placing the indicator inside the Sterrad sterilizer chamber, as it is intended exclusively for use with Sterrad systems.
Is the Sterrad Cyclesure Biological Indicator reusable, and if not, why?
No, it is explicitly designed for single-use only. Since it contains biological spores to validate sterilization cycles, reuse could compromise the integrity of the test results and potentially introduce contamination risks, making it unsafe and unreliable for repeated cycles.
What regulatory pathway does the Sterrad Cyclesure Biological Indicator follow, and what does that mean for buyers?
The device follows the FDA’s 510(k) clearance pathway (K103222) and is classified as a Class II medical device. This means it has been determined to be substantially equivalent to a legally marketed predicate device and meets FDA standards for biological sterilization process indicators, ensuring compliance with hospital sterilization protocols.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CYCLESURE® 24 Biological Indicator (BI) | ASP, STERRAD CYCLESURE BIOLOGICAL INDICATOR (K994055) — FDA 510 (k) | Innolitics, STERRAD CYCLESURE BIOLOGICAL INDICATOR (K103222) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K103222 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Sterilization Products
Sources (1)
- FDA 510(k) K103222 24 fields · synced Sep 19, 2026